Drugmaker Merck & Co. withdraws EU cancer drug application

WHITEHOUSE STATION, N.J. — Drugmaker Merck & Co. is withdrawing its application for European approval of the potential cancer treatment ridaforolimus, which was rejected earlier this year by U.S. regulators.

The Whitehouse Station, N.J., company said Thursday a European Medicines Agency committee indicated that data provided in the application was not sufficient to allow licensing the drug as a maintenance treatment for patients with soft tissue sarcoma or a form of bone cancer.

The agency had accepted the drugmaker’s application in August 2011, and the Committee for Medicinal Products for Human Use was reviewing it.

In June, Merck said the U.S. Food and Drug Administration decided that it will not approve ridaforolimus unless Merck conducts further testing.

Advertisement

Merck had asked the FDA to approve ridaforolimus as a maintenance therapy, meaning it would be used to help repress sarcoma of the bone and tissue in patients whose cancer is already in remission. The FDA has only approved a few cancer drugs for maintenance use, and a panel had recommended against approving ridaforolimus in March.

Merck acquired the rights to ridaforolimus from Ariad Pharmaceuticals Inc. of Cambridge, Mass., in 2010. Last year, Merck paid Ariad $25 million after filing for European approval for the drug.

Merck is still developing ridaforolimus as a possible treatment for breast and lung tumors in combination with other drugs, but the company has yet to decide whether to do additional testing for the treatment of sarcomas, a company spokeswoman said by email.